COVID-19 IgG IgM Antibody Rapid Test Kit Professional Use 20 Test Labnovation

Product Specification

Rapid Antibody Test Kit COVID-19 IgG/IgM Antibody Rapid Test Kit Professional Use 20 Test Rapid Antibody Test Kit

Intended Use
COVID-19 IgG/IgM Antibody Rapid Test Kit is a rapid test intended for the qualitative detection of the IgM and IgG antibodies to SARS-CoV-2 in human serum, plasma or whole blood sample from patients suspected of COVID-19 infection. The test Kit for professional use only. It is an aid in the diagnosis of the patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and results of other laboratory tests. But to be attention the test Results from this test kit should not be used as the sole basis for diagnosis. The test provides preliminary test results.
Specification

Main Components

• Test Cassettes
• Disposable Pipettes
• Sample Buffer
• Instruction For Use

Product Advantage

• Sinple 
• Fast 
• Accurate
• One-step operateion
• Read The result within 10-15 mins

Use Step

For Serum/Plasma

1. Remove the test device from the sealed pouch, place it on a clean and level surface with the sample well up.

2. Add serum or plasma (10µl) vertically into the sample well .

3. Add two (2) drops (80-100µl) of sample buffer into the sample well .

4. Observe the test results immediately within 15~20 minutes, the result is invalid over 20 minutes.

For Whole Blood

1. Remove the test cassette from the sealed pouch, place it on a clean and level surface with the sample well up.

2. Add whole blood (20µl) vertically into the sample well .

3. Add two (2) drops (80-100µl) of sample buffer into the sample well .

4. Observe the test results immediately within 15~20 minutes, the result is invalid over 20 minutes.

 
Interpretation of result

• POSITIVE: Two or three distinct red lines appear. One line should be in the control region (C) and the other line would be in the test region (IgG line, IgM line or both).
• NEGATIVE: One red line appears in the control region(C). No red or pink line appears in the test region (IgG line, IgM line).
• INVALID: No red lines appear or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.

Storage And Expiry

Store as packaged in the sealed pouch at 2-30℃, avoid hot and sunshine, dry place, valid for 12 months. DO NOT FREEZE. Some protective measures should be taken in hot summer and cold winter to avoid high temperature or freeze-thaw. Do not open the inner packaging until ready, it must be used in one hour if opened (Humidity≤60%, Temp: 20℃-30℃). Please use immediately when the humidity＞60%.

Limitation

• This reagent is designed for the qualitative screening test. Concentration of SARS-CoV-2 IgM/IgG antibody cannot be determined by this qualitative test. The depth of the T-line(IgG/IgM) color is not necessarily related to the concentration of the antibody in the sample.
• The results of the reagent are only for clinical reference, which is not the only basis for clinical diagnosis and treatment. A confirmed diagnosis and treatment should only be made by a physician after all clinical and laboratory findings have been evaluated.

Precaution

• For IN VITRO diagnostic use only.
• Reagents should be used as soon as possible after opened. This reagent cannot be reused for disposable.
• The test device should remain in the sealed pouches until use. If sealing problem happens, do not test. Don’t use after the expiration date.
• All specimens and reagents should be considered potentially hazardous and handled in the same manner as an infectious agent after use.

Application

• Center for Disease Control and Prevention
• Primary Health Care Institution
• Prision / Detention Center / Drug Rehabilitation Center

FAQ

• How about the MOQ?

MOQ is more than 10000 pcs, but our sales team will advise you how much to order based on the products you need, national market conditions, international logistics costs and other factors

• Which certificate you have?

CE, ISO13485

• Do you manufacturer or trading company?

We are factory, all product we supply is R&D and produce by ourself.

• Register your products in our country?

Yes. We can offer full files for you to register.

• Lead time?

Stock 3-7 days in general. Or please contact us by email for specific lead time base on your order quantities.

• Support ODM or OEM?

Yes we support both. If needed,welcome to discuss details with us.